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Trial registered on ANZCTR


Registration number
ACTRN12617001441303
Ethics application status
Approved
Date submitted
2/10/2017
Date registered
11/10/2017
Date last updated
15/06/2022
Date data sharing statement initially provided
15/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Empowering Elderly Patients to Establish their own Goals of Care
A pilot Study in the Emergency Department
Scientific title
Empowering older patients to make informed end-of-life decisions. A new model of service in the emergency department: The Goals of Care Initiative
Secondary ID [1] 292636 0
Nil known
Universal Trial Number (UTN)
U1111-1200-5752
Trial acronym
GoC
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Advanced chronic disease 304374 0
Frailty 304375 0
Reattendances to Hospital Emergency Departments 304863 0
non-beneficial (futile) treatments 304864 0
Condition category
Condition code
Cardiovascular 304171 304171 0 0
Other cardiovascular diseases
Respiratory 304172 304172 0 0
Chronic obstructive pulmonary disease
Neurological 304176 304176 0 0
Dementias
Renal and Urogenital 304177 304177 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
--Screening for frailty with Rockwood (CFS) instrument and screening for risk of death with CriSTAL (Criteria for Screening and Triaging to Appropriate aLternative care) among patients aged 80+ years presenting at the participating hospital on 'intervention days'
--Guided Goals of Care conversation takes place face-to-face in the emergency department led by purpose-trained nurses who will also document patient values and preferences, and type of care which is coordinated by hospital. The 30-45 minute Goals of care conversation is led by Clinical Nurse Consultants trained using the PREPARE materials and the End-of-Life Essential online modules. Patient preferences are elicited using a semi-structured guide and the final version in conventional bright yellow paper is placed in the patient's clinical notes.

--Communication with admitting teams about patient preferences and goals of care occurs on the same day, either in the emergency department or on the ward, depending on where the conversation ends.
Intervention code [1] 299272 0
Behaviour
Intervention code [2] 299273 0
Behaviour
Comparator / control treatment
Patients aged 80+ years presenting at emergency department in the same hospital on 'non-intervention days'. Will be screened for frailty with Rockwood (CFS) instrument and screening for risk of death with CriSTAL (Criteria for Screening and Triaging to Appropriate aLternative care). The control 'treatment' is usual care by hospital staff for older people at the end of life during the same study period.
The Control hospital is an equivalent tertiary facility which cannot be identified to prevent contamination.
Control group
Active

Outcomes
Primary outcome [1] 303552 0
Re-admission rates as determined by electronic records
Timepoint [1] 303552 0
within 3 months of initial assessment in emergency department the evaluation team will check the above outcome
Primary outcome [2] 303553 0
Emergency Department re-attendances extracted from electronic records
Timepoint [2] 303553 0
Within 3 months of initial assessment in emergency department the evaluation team will check the above outcome
Primary outcome [3] 303554 0
Proportion of patients formalising advance care directives during hospitalisation or post-discharge, as determined by self-report at the follow-up call
Timepoint [3] 303554 0
within 3 months of initial assessment in emergency department the evaluation team will check the above outcome
Secondary outcome [1] 339346 0
Proportion of patients/families satisfied with care received as determined by self-report at the follow-up call
Timepoint [1] 339346 0
one and three months
Secondary outcome [2] 339347 0
Proportion of patient/surrogates refusing participation or withdrawing (acceptability) as determined by review of the recruitment logs
Timepoint [2] 339347 0
Refusal and withdrawals will be available at Baseline and at 3 months post-initial assessment at completion of follow-up.
Secondary outcome [3] 339348 0
Proportion of patients where treatment received is aligned with wishes expressed in the Goals of Care conversation. This information is part of the follow-up questionnaire specifically designed for this study. If there is opportunity for data linkage we will also check the hospital records to determine treatment received.
Timepoint [3] 339348 0
Within 3 months of initial assessment in the emergency department
Secondary outcome [4] 339660 0
ED Staff satisfaction with the new model of service as measured by an in-depth interview purpose-designed for this study
Timepoint [4] 339660 0
At the end of the data collection (follow-up period)

Eligibility
Key inclusion criteria
Older people aged 80+ years presenting at emergency department and being admitted for at least one night and able to provide written consent to enable data linkage and follow-up telephone call at one and 3 months.
Minimum age
80 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Unable to communicate in English unless an interpreter or relative available.
-No surrogate present (in case of cognitive impairment or non-English speaking background)
-CriSTAL score of less than 6

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No concealment. Neither staff delivering the intervention will have the opportunity to choose. Specific days will be Intervention or non-intervention days assigned using randomly generated numbers by an external party
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer generated random numbers for weekdays only. Consecutive patients will be approached for eligibility and recruitment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
To prevent contamination, full days will be assigned to intervention or non-intervention in advance. All patients recruited on any one day will receive the same model of service (new model or usual care) depending on assignment for that particular date.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Initial analysis will be conducted at the cluster level comparing the control and intervention arms on primary and secondary outcomes. Analyses will then be extended to the individual level by using mixed models to account for the clustered design. Any baseline differences will include fixed effect adjustment for site within this model.

Evaluation of satisfaction with model of service at end-of-life in each arm will be part of surveys and the in-depth interviews with staff and brief survey/structured interviews with patients/surrogates. Thematic analyses and descriptive statistics will be used.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Main investigator resigned before study completion
Date of first participant enrolment
Anticipated
23/10/2017
Actual
24/10/2017
Date of last participant enrolment
Anticipated
27/04/2018
Actual
30/04/2018
Date of last data collection
Anticipated
31/07/2018
Actual
31/07/2018
Sample size
Target
480
Accrual to date
Final
419
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9150 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 17661 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 297265 0
Charities/Societies/Foundations
Name [1] 297265 0
HCF Research Foundation
Country [1] 297265 0
Australia
Funding source category [2] 297733 0
Government body
Name [2] 297733 0
National Health and Medical Research Council
Country [2] 297733 0
Australia
Primary sponsor type
University
Name
South Western Sydney Clinical School, UNSW
Address
Level 3, Ingham Institute.
1 Campbell Street, Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 296682 0
Hospital
Name [1] 296682 0
Liverpool Hospital
Address [1] 296682 0
Elizabeth St, Liverpool NSW 2170
Country [1] 296682 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298382 0
South Western Sydney Local Health District Ethics Committee
Ethics committee address [1] 298382 0
Ethics committee country [1] 298382 0
Australia
Date submitted for ethics approval [1] 298382 0
24/02/2017
Approval date [1] 298382 0
29/05/2017
Ethics approval number [1] 298382 0
HREC/17/LPOOL/88 local project HE 17/042

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76902 0
Prof Ken Hillman
Address 76902 0
The Simpson Centre for Health Services Research
Level 3
The Ingham Institute for Applied Medical Research
1 Campbell Street
Liverpool NSW 2170
Country 76902 0
Australia
Phone 76902 0
+61 2 8738 9372
Fax 76902 0
Email 76902 0
k.hillman@unsw.edu.au
Contact person for public queries
Name 76903 0
Ken Hillman
Address 76903 0
The Simpson Centre for Health Services Research
Level 3
The Ingham Institute for Applied Medical Research
1 Campbell Street
Liverpool NSW 2170
Country 76903 0
Australia
Phone 76903 0
+61 2 8738 9372
Fax 76903 0
Email 76903 0
k.hillman@unsw.edu.au
Contact person for scientific queries
Name 76904 0
Paul Middleton
Address 76904 0
Emergency Department
Liverpool Hospital
Elizabeth St, Liverpool NSW 2170
Country 76904 0
Australia
Phone 76904 0
+61 2 8738 3679
Fax 76904 0
Email 76904 0
Paul.Middleton@sswahs.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.